CompletedPhase 1

A Phase 1 Study, to Evaluate the Effect of ADV7103 on Gastric pH Under Fed and Fasting Conditions in Adult Healthy Participants.

France12 participantsStarted 2025-02-25

Plain-language summary

This was a Phase 1, single-center, randomized, controlled, Latin-square, open-label study to evaluate the effect of ADV7103 on the gastric pH, after administering a single oral dose of ADV7103 in healthy adult participants under fasting and fed conditions

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. At least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., appropriate age) and follicle-stimulating hormone (FSH) in the range for menopausal female confirmed by blood test according to current local standards at screening, except if treated with hormone replacement therapy (HRT\]).
✓. Those with history of hysterectomy or surgical removal of both ovaries or bilateral tubal ligation performed at least 90 days prior to screening.

What they're measuring

The effect of a single dose of ADV7103 on gastric pH under fasting and fed conditions in adult healthy participants.

Timeframe: 4 days

Trial details

NCT IDNCT07446881

SponsorAdvicenne Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-15

View on ClinicalTrials.gov More EFFECT OF ADV7103 ON GASTRIC PH trials